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Animal Assisted Therapy in a Pediatric Setting (AAT)

Primary Purpose

Developmental Delays, Global Developmental Delay, Stroke

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Animal Assisted Therapy
Sponsored by
Children's Hospitals and Clinics of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Developmental Delays focused on measuring Occupational Therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inpatient Occupational Therapy Referrals
  • Ages 0-21 years

Exclusion Criteria:

  • Patients who are uncomfortable with dogs
  • Patients who exhibits violent behavior
  • Animal Allergies
  • Patients are unable to work with a dog
  • Patients who exhibit severe cognitive delays

Sites / Locations

  • Children's Hopsitals and Clinics of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Animal Assisted Therapy Visit 1

Animal Assisted Therapy at Visit 2

Arm Description

Standard OT Therapy with Animal Assisted Therapy at Visit 1 and Not at Visit 2

Standard OT Therapy with Animal Assisted Therapy at Visit 2 and not Visit 1

Outcomes

Primary Outcome Measures

OT Participation scale
The patients response to therapy can be measures using the following behavior domains (cognition, fine motor, activities and daily living, feeding skills, active range of motion/activities, and functional Transfers).

Secondary Outcome Measures

Vital Signs (Blood Pressure and heart rate)
Heart rate and blood pressure will be measured to assess if AAT minimizes stress and anxiety.

Full Information

First Posted
January 28, 2011
Last Updated
February 13, 2014
Sponsor
Children's Hospitals and Clinics of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01441674
Brief Title
Animal Assisted Therapy in a Pediatric Setting
Acronym
AAT
Official Title
The Effectiveness of Animal Assisted Therapy for Children Hospitalized in a Pediatric Setting
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospitals and Clinics of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose for this study is to determine if children who receive Occupational Therapy while they are an inpatient in the hospital will be more motivated to participate in therapy as well as increase the amount of time they will work during that particular session when a therapy dog is present during their sessions. The investigators will also be collecting data regarding a child's heart rate and blood pressure prior to the session starting and ending to determine if having a therapy dog present also helps relax a child.
Detailed Description
The primary objective of this study is to evaluate if a patient in the pediatric acute care setting receiving Occupational Therapy (OT) services in adjunct with animal assisted therapy (AAT) are more motivated to actively participate in the therapy session for a longer period of time. Methods: Thirty inpatients will be recruited to participate in this study. This study will utilize a randomized crossover study design where the patients act as their own control. The treatment period for hospitalized patients will include an on off pattern of incorporating AAT into their OT session. Patients' participation of therapy will be assessed with a participation scale (see Figure 2) and the OT session time. Patients will be evaluated for OT and the therapist will determine goals based on functional status and needs of the particular patient. Goals will be determined by providing a functional evaluation based upon Occupational Therapists clinical observation, developmental standards and current functional level of the patient. Patients who are potential candidates for this study will be hospitalized at Children's Hospitals and Clinics of Minnesota on the St. Paul campus. All inpatients stated to have decreased functional skills that have been referred by a physician to OT will be invited to participate this study. Patients have a difficult time participating in various therapies due to emotional stress, anxiety, and feeling uncomfortable with the hospital environment. Limited studies have demonstrated the value of AAT used in conjunction with OT for children, regardless of diagnosis within the hospital setting. Results of this study can justify the use of this valuable therapy not only for the selected population, but also for other disciplines such as physical and speech therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Delays, Global Developmental Delay, Stroke, Cancers, Seizures Disorders, Behavior Problems, Feeding Disorder, Developmental Delay in Feeding
Keywords
Occupational Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Animal Assisted Therapy Visit 1
Arm Type
Experimental
Arm Description
Standard OT Therapy with Animal Assisted Therapy at Visit 1 and Not at Visit 2
Arm Title
Animal Assisted Therapy at Visit 2
Arm Type
Experimental
Arm Description
Standard OT Therapy with Animal Assisted Therapy at Visit 2 and not Visit 1
Intervention Type
Behavioral
Intervention Name(s)
Animal Assisted Therapy
Other Intervention Name(s)
Group 1 and Group 2
Intervention Description
There will be a therapy dog and dog trainer present working with the patient for the AAT arm.
Primary Outcome Measure Information:
Title
OT Participation scale
Description
The patients response to therapy can be measures using the following behavior domains (cognition, fine motor, activities and daily living, feeding skills, active range of motion/activities, and functional Transfers).
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Vital Signs (Blood Pressure and heart rate)
Description
Heart rate and blood pressure will be measured to assess if AAT minimizes stress and anxiety.
Time Frame
4 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inpatient Occupational Therapy Referrals Ages 0-21 years Exclusion Criteria: Patients who are uncomfortable with dogs Patients who exhibits violent behavior Animal Allergies Patients are unable to work with a dog Patients who exhibit severe cognitive delays
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Iammatteo, OT
Organizational Affiliation
Children's Hospitals and Clinics of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hopsitals and Clinics of Minnesota
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States

12. IPD Sharing Statement

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Animal Assisted Therapy in a Pediatric Setting

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